At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients: A Single-arm Phase I Trial
In Brief
A Phase 1 clinical trial evaluating Toripalimab, Paclitaxcel, and 3 other interventions for Oral Cancer and 3 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.
Study Details
Timeline
Interventions
Neoadjuvant therapy with Toripalimab of 240mg, iv, qd, on day 1, 22
Neoadjuvant therapy with Paclitaxcel of 260mg/m2, iv, qd, on day 1, 22
Neoadjuvant therapy with Cisplatin of 75mg/m2, iv, qd, on day 1, 22
Radical surgery will be performed on the 43th-48th after initiation of inductive therapy.
Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathological diagnosis.